Category Archives: Scott Gottlieb

FDA Administrator Scott Gottlieb announced this week that he is resigning his position to… get this … spend more time with his family.

Yup, that really actually is his excuse. And this came a couple of weeks after he insisted he wasn’t going anywhere … which was a pretty big clue that he was on his way out.

And he was totally not forced out by Republicans or by the tobacco industry because … he insists he was not forced out by Republicans or the tobacco industry. Repeatedly. So, that’s the end of discussion.

Gottlieb was a total anomaly in the Trump Administration, someone who actually was doing his job. Someone who wasn’t terribly controversial and who didn’t completely dismantle the agency he was put in charge of.

Honestly, for two years, I’ve been scratching my head at it. Trump has clearly put pro-industry, pro-business, anti-regulatory shills in charge of many federal agencies. And it’s clear that their role is to simply dismantle that agency.

Gottlieb was the outlier. He actually was fairly anti-tobacco industry and he was particularly anti-vaping industry (and I don’t differentiate much between the vaping and tobacco industry because the tobacco industry has a controlling interest about 75-80 percent of the vaping industry) was using the FDA to crack down pretty harshly on the vaping industry, mostly over the huge increase in recent years in teen vaping.

Gottlieb had gone so far as to threaten to completely ban vaping products completely. He didn’t follow through with that threat, but he did propose a bunch of new regulations toward vaping products, including rules that vaping products can only be sold in areas completely closed off to minors. He also proposed banning menthol cigarettes.

So, I wasn’t surprised when he suddenly announced this week he was resigning.

Hah, the kicker? He actually boldly announced two months ago he wasn’t going anywhere. That told me right there that there was political pressure coming down on him because he was too anti-industry for Republicans’ taste.

This New York Times article goes to great length to highlight Gottlieb and the Trump Administration’s denials that he was forced out by Big Tobacco and Republicans. He denies it a little too much, frankly. Yeah, because the Trump Administration ALWAYS tells the truth about these things, right? And the “I wanted to spend more time with my family” is the oldest excuse in the book.

Dr. Gottlieb has been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some key parts of the F.D.A.’s strategy to prevent youths from vaping. Republican Senator Richard Burr blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.

Dr. Gottlieb said these protests had no role in his departure.

“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.

Dr. Gottlieb said these protests had no role in his departure.

“There’s no intrigue here,” he said in an interview. A senior White House official said Dr. Gottlieb was not pressured to leave and that the President was “very fond” of him.

Gottlieb’s proposed regulations were in the “pending” stage. Expect them to remain there … or to be dropped entirely. From the article:

Dr. Gottlieb said he planned to advance the F.D.A.’s pending tobacco regulations before he leaves. And he was confident, he said, that the agency’s guidance on restricting flavored e-cigarettes would be issued before he left. He acknowledged, however, that he could not predict the fate of his proposals to ban menthol in cigarettes and reduce nicotine to nonaddictive levels in cigarettes.

Industry analysts expressed optimism that those initiatives would, in fact, now end.

“We think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty,” Bonnie Herzog, a managing director of equity research at Wells Fargo Securities, wrote in an email to clients. “We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives.”

So, I expect little or nothing to be done about vaping, teen vaping, menthol cigarettes for the next two years. Gottlieb was the wrong guy, in the wrong administration, to make it happen.

It sounds like a hammer might be coming down very soon, one way or the other.

The FDA is really ratcheting up the rhetoric level against e-cigarettes this week, with FDA Chief Scott Gottlieb saying new data that is soon coming out is showing that the problem of e-cigarette use by teens has grown far worse.

They sound serious. I get a little jaded that the FDA will do anything about nicotine products, but I’ve never seen such strong governmental rhetoric against e-cigarettes before.

FDA Commissioner Scott Gottlieb said the agency will soon release data that show a “substantial increase” in youth vaping this year compared with 2017. He said the problem had reached “epidemic proportion.”

“I have grown increasingly concerned around what we see as rising youth use in these products, and I’m disappointed in the actions the companies have taken to try to address this,” Gottlieb said in an interview.

The FDA told five major e-cigarette manufacturers Wednesday to come up with ways to address youth use in 60 days or the agency could require them to stop selling flavored products that appeal to children. The products being targeted are: Juul, Altria Group Inc.’s MarkTen, Fontem Ventures’s blu, British American Tobacco’s Vuse and Logic.

Whoa, 60 days, so that will be mid-November.

And they’re going after the big boys. Blu, Vuse, MarkTen are about 75 percent of the e-cig market, not counting Juuls.

This new sense of urgency toward e-cigs appears to be driven somewhat by concerns over the exploding use of Juuls. Juuls are a relatively new kind of e-cig that look like a flash drive and are powered by actually plugging them into a laptop computer. They’re incredibly popular with kids.

From the Bloomberg article:

“This could result in a bullet through the head of Juul, the driver of youth initiation,” said Nico von Stackelberg, an analyst with Liberum in London.

To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping.

“I certainly am in possession of evidence that warrants that,” Gottlieb said. He declined to disclose the evidence.

Of the 3.6 million middle- and high-school students who said in 2017 they are current tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention.

“There is no question that a lot of the youth use is being driven by Juul,” Gottlieb said.

“Juul was a game changer,” said Matthew Myers of the Campaign for Tobacco-Free Kids. He listed three reasons the company became so successful: It figured out how to deliver high levels of nicotine in a way that wasn’t harsh; it packaged the product in a streamlined, clever way; and it developed a social media and advertising campaign that made a Juul e-cigarette “cool and hip.”

Keep in mind, this issue here isn’t that e-cigs are as bad as cigarettes. But,they are a nicotine-delivery system and they are effectively getting teenagers physically addicted to nicotine. And nicotine addiction is a bad thing in of itself, regardless of the delivery system. And the issue here is e-cig companies have been BRAZENLY marketing e-cig products to kids for years. I know I’ve been railing about it for years.